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Photodynamic Therapy for Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status

Unknown status

Phase

Phase 1

Locations

Switzerland

Study Type

Interventional

Intervention

Photodynamic therapy with Gliolan

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria: ? An established and documented diagnosis of UC

Moderate and severe active distal UC with a Mayo score of 6-10 and proctosigmoidoscopy score of 2
Distal UC as assessed by proctosigmoidoscopy, i.e. major lesions between the sigmoid colon and rectum with lesions not extending the splenic flexure
Glucocorticosteroids, aminosalicylates and certain immunosuppressants are permitted under specific conditions as defined in the concomitant medication section

Exclusion criteria: ? Have participated in any other investigational study or received an experimental therapeutic procedure considered to interfere with the study in the 4 weeks preceding SD1

UC complications (e.g. strictures, pouchitis)
Use of the following immunosuppressants in 12 weeks preceding SD1: cyclosporine, thalidomide derivatives, mycophenolate mofetil
Use of antibiotics in 2 weeks preceding SD1
Use of non steroidal anti-inflammatory drugs (NSAIDs) in 2 weeks preceding SD1
Use of anti-tumor necrosis factor (TNF) or other biologics in 8 weeks preceding SD1
Porphyria, erythropoietic protoporphyria or hypersensitivity to porphyrins
Uncontrolled medical conditions, requiring surgical or pharmacological treatment
Inadequate bone marrow reserve: White blood cell (WBC) < 3.5x109/L, neutrophils < 1.0x109/L, thrombocytes < 100x109/L, haemoglobin (Hb) < 8.5 g/dL or coagulation abnormalities
Inadequate liver function: total bilirubin > 1.5 x upper limit of normal values aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), or alkaline phosphatase > 2.5 x upper limit of normal
Have inadequate renal function, defined by serum creatinine > 250 µmol/L
Serious concomitant disease (e.g. severe cardiovascular disease, chronic obstructive pulmonary disease)
History of cancer < 5 years
History of alcohol and/or drug abuses
Pregnant or lactating women and fertile women unless surgically sterile or using one highly effective method + a barrier method till the end of the study (SD29)Female patients must not be pregnant or lactating

Sites / Locations

Department of Gastroenterology and HepatologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Photodynamic therapy with Gliolan

Arm Description

Intervention: Laser light illumination with a cylindrical light diffuser (Model RD, Medlight SA) is performed 3 hours after administration of 15 mg/kg 5-aminolevulinic acid (5-ALA, Gliolan)

Outcomes

Primary Outcome Measures

to determine the proportion of patients with moderate to severe active distal UC with a clinical response to low dose PDT in patients at study day (SD) 8. A clinical response is defined as a total Mayo score <2 with no subscore >1.

The screening phase consists of 1 week (SD-7 - SD0), the treatment phase of 4 weeks (SD1-SD29), and the follow-up evaluation phase of 4 weeks (SD30-SD57), equating to an overall duration of 9 weeks per patient. It is foreseen to have at least 3 participating investigational sites to complete accrual of the first cohort in 3 months, and the second cohort, if appropriate in an additional 3 months. In case of low recruitment, extra sites will be asked for participation. Hence the study duration from study initiation until last patient whom completed the study is 8 months to reach the primary analysis of the study. The follow-up analysis will be completed about 3 months later.

Secondary Outcome Measures

Full Information

NCT ID

NCT01697670

First Posted

September 28, 2012

Last Updated

November 2, 2012

Sponsor

University of Zurich

Collaborators

Swiss National Science Foundation

1. Study Identification

Unique Protocol Identification Number

NCT01697670

Brief Title

Photodynamic Therapy for Ulcerative Colitis

Official Title

A Multicenter, Open Phase II Study to Assess the Effect and Safety of "Low Dose" Photodynamic Therapy in Patients With Moderate to Severe Active Distal Ulcerative Colitis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Unknown status

Study Start Date

September 2012 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

December 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Zurich

Collaborators

Swiss National Science Foundation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Objectives: Primary: The primary study objective is to determine a clinical response as assessed by the Mayo score to low dose PDT in patients with moderate to severe active distal UC. Secondary: The secondary study objectives are to assess the effect on inflammation and the safety and tolerability of low dose PDT in patients with moderate to severe active distal UC. This is a multicenter, open phase II study that will enroll a maximum of 20 eligible patients with moderate to severe active distal UC. The first 10 eligible patients, the first cohort, will receive PDT at a 10 Joule per square centimetre (J/cm2) dose intensity. If no clinical response is observed in the first 7 eligible patients, the study will be stopped due to lack of efficacy. If at least 1 clinical response is observed in the first 7 patients, the first cohort will be completed to a total of 10 eligible patients Trial with medicinal product

Detailed Description

Subsequently, the following algorithm will apply: >3 clinical responders at SD8, then another 10 patients, the second cohort, will be exposed to the same PDT dose intensity <3 clinical responders, without adverse proctosigmoidoscopic observations at SD8, then the second cohort, will be exposed to the next higher PDT dose intensity 15 J/cm2 <3 clinical responders, with adverse proctosigmoidoscopic observations at SD8, then the second cohort, will be exposed to the next lower PDT dose intensity 5 J/cm2 The safety will be continuously evaluated throughout the study. The screening phase consists of 1 week (SD-7 - SD0), the treatment phase of 4 weeks (SD1-SD29), and the follow-up evaluation phase of 4 weeks (SD30-SD57), equating to an overall duration of 9 weeks per patient. It is foreseen to have at least 3 participating investigational sites to complete accrual of the first cohort in 3 months, and the second cohort, if appropriate in an additional 3 months. In case of low recruitment, extra sites will be asked for participation. Hence the study duration from study initiation until last patient whom completed the study is 8 months to reach the primary analysis of the study. The follow-up analysis will be completed about 3 months later. Stopping rules: Requirement for prohibited medication or surgical procedure Requirement to increase the dose of permitted medication SAE thought to be attributable to PDT Grade III and IV toxicities (CTC v3.0) thought to be attributable to PDT Patients request to be withdrawn Lost to follow-up Investigational Medicinal Device: All patients will drink 50 ml orange juice containing 15 mg/kg 5-aminolevulinic acid (5-ALA). After 3 hours, the lesions will be illuminated with red light at 635 nm using a cylindrical light diffuser (Model RD, Medlight SA) in a white diffusing inflatable balloon catheter (model CDB OEB, Medlight SA) at a fluence rate of 65.5 mW/cm2 over 153 seconds resulting in a total light dose of 10 J/cm2. The first cohort will be treated at a ligh

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ulcerative Colitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Photodynamic therapy with Gliolan

Arm Type

Experimental

Arm Description

Intervention: Laser light illumination with a cylindrical light diffuser (Model RD, Medlight SA) is performed 3 hours after administration of 15 mg/kg 5-aminolevulinic acid (5-ALA, Gliolan)

Intervention Type

Drug

Intervention Name(s)

Photodynamic therapy with Gliolan

Other Intervention Name(s)

5-aminolaevulinic acid (5-ALA)

Intervention Description

Laser light illumination with red light at 635 nm using a cylindrical light diffuser (Model RD, Medlight SA) in a white diffusing inflatable balloon catheter (model CDB OEB, Medlight SA) at a fluence rate of 65.5 mW/cm2 over 153 s resulting in a total light dose of 10 J/cm2 is performed 3 hours after administration of 15mg/kg bodyweight Gliolan

Primary Outcome Measure Information:

Title

Description

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: ? An established and documented diagnosis of UC Moderate and severe active distal UC with a Mayo score of 6-10 and proctosigmoidoscopy score of 2 Distal UC as assessed by proctosigmoidoscopy, i.e. major lesions between the sigmoid colon and rectum with lesions not extending the splenic flexure Glucocorticosteroids, aminosalicylates and certain immunosuppressants are permitted under specific conditions as defined in the concomitant medication section Exclusion criteria: ? Have participated in any other investigational study or received an experimental therapeutic procedure considered to interfere with the study in the 4 weeks preceding SD1 UC complications (e.g. strictures, pouchitis) Use of the following immunosuppressants in 12 weeks preceding SD1: cyclosporine, thalidomide derivatives, mycophenolate mofetil Use of antibiotics in 2 weeks preceding SD1 Use of non steroidal anti-inflammatory drugs (NSAIDs) in 2 weeks preceding SD1 Use of anti-tumor necrosis factor (TNF) or other biologics in 8 weeks preceding SD1 Porphyria, erythropoietic protoporphyria or hypersensitivity to porphyrins Uncontrolled medical conditions, requiring surgical or pharmacological treatment Inadequate bone marrow reserve: White blood cell (WBC) < 3.5x109/L, neutrophils < 1.0x109/L, thrombocytes < 100x109/L, haemoglobin (Hb) < 8.5 g/dL or coagulation abnormalities Inadequate liver function: total bilirubin > 1.5 x upper limit of normal values aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), or alkaline phosphatase > 2.5 x upper limit of normal Have inadequate renal function, defined by serum creatinine > 250 µmol/L Serious concomitant disease (e.g. severe cardiovascular disease, chronic obstructive pulmonary disease) History of cancer < 5 years History of alcohol and/or drug abuses Pregnant or lactating women and fertile women unless surgically sterile or using one highly effective method + a barrier method till the end of the study (SD29)Female patients must not be pregnant or lactating

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marianne Ortner, MD

marianne.ortner@usz.ch

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marianne Ortner, MD

Organizational Affiliation

University Hospital Zurich, Division Gastroenterology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Gastroenterology and Hepatology

City

Zurich

Country

Switzerland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria Anna Ortner, MD

Phone

+41 792300891

ma.ortner@bluewin.ch

12. IPD Sharing Statement

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Photodynamic Therapy for Ulcerative Colitis

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